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The goal of this clinical trial is to learn if 8 sessions of brief exposure and exercise therapy works to treat Post Traumatic Stress Disorder (PTSD) in adults. This study will also learn if participants think brief exposure and exercise therapy is a good and doable treatment. and The main questions it aims to answer are:
Participants will:
A community sample (n=6) of adults with PTSD will receive eight sessions of standardized brief exposure therapy with six sessions of imaginal exposures and aerobic exercise. This clinical trial will be the first study demonstrate the effectiveness of an exposure-only therapy and exercise treatment by isolating and targeting safety learning using imaginal exposures. This approach will address gaps in the literature by demonstrating treatment effectiveness, mechanistic engagement, and patients' perceptions of a brief imaginal exposure treatment combined with aerobic exercise. Addressing these gaps through a preliminary clinical trial that establishes feasibility and treatment effectiveness is a necessary first step before exerting substantial time and money on a large-scale clinical trial.
Aligned with an experimental therapeutics approach, the proposed study will take advantage of single-case experimental design (SCED) to explore changes in PTSD symptom severity and exposure therapy mechanisms (i.e., belief change, experiential avoidance, and emotional intensity) within each participant. SCEDs are parsimonious research designs that are ideal for investigating mechanisms and the effectiveness of interventions. SCEDs use each subject as their own control, resulting in high internal validity and the ability to examine effect sizes across subjects.
Upon referral to the study, participants will complete a brief battery of self-report questionnaires to screen for eligibility. Likely eligible participants, determined by the prescreening, will be given a link to schedule an intake with PI or other graduate student research personnel to complete informed consent and assessments to evaluate inclusion/exclusion criteria. Eligible participants will then be randomized to either a 3, 4 or 5 week baseline period, where participants will complete weekly self-report questionnaires to assess PTSD symptoms and exposure therapy mechanisms. Participants fill out a questionnaire battery before, during, and after treatment resulting in a total of 10-14 weeks of self-report assessments. After the baseline assessment phase, participants will complete the first session of PE, which focuses on psychoeducation and treatment planning, six sessions of imaginal exposures and exercise, and a final PE session discussing relapse prevention and future directions. During the six imaginal exposure sessions (sessions 2-7), participants will complete 20 minutes of imaginal exposure to traumatic memories, 10 minutes of emotional processing, and then 20 minutes of moderate-intensity exercise (i.e., 70-75% of MHR) on a stationary bike with 3 minutes of warmup and 2 minutes of cool-down. Proximal measures for exposure mechanisms will be assessed during treatment sessions (e.g., subjective units of distress) to align with distal measures of exposure therapy, which are assessed in the weekly self-report batteries. Following completion of the treatment, participants will be asked to provide satisfaction ratings on the treatment.
PTSD symptom severity will be assessed weekly to investigate treatment efficacy (Aim 1). Acceptability will be evaluated using a self report patient satisfaction questionnaires (Aim 2). Adherence to the treatment protocol will be used to characterize feasibility (Aim 3).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brief exposure therapy and exercise 3 week | Experimental | Participants are randomized into the 3 week baseline condition before receiving the exposure therapy and exercise intervention. |
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| Brief exposure therapy and exercise 5 week | Experimental | Participants are randomized into the 5 week baseline condition before receiving the exposure therapy and exercise intervention. |
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| Brief exposure therapy and exercise 4 week | Experimental | Participants are randomized into the 4 week baseline condition before receiving the exposure therapy and exercise intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief exposure therapy and exercise | Behavioral | Treatment provided in this study includes an open label brief imaginal exposure therapy for Post Traumatic Stress Disorder (PTSD) and moderate intensity aerobic exercise (i.e., 70-75% max heart rate). Participants all receive 30 minutes of psychotherapy and 25 minutes of exercise. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in PTSD Checklist for DSM-5 (PCL-5) | The PCL-5 is a 20-item self-report questionnaire used to assess PTSD symptom severity. Each of the 20 PCL-5 items corresponds to symptoms of PTSD in the DSM-5. Items are rated on a Likert scale from 0 (not at all) to 4 (extremely) based upon how bothered participants are by each symptom. Items on the PCL-5 are summed, resulting in a total score of PTSD symptom severity from 0-80. Scores >30 indicate probable PTSD. | Up to 15 weeks. |
| Patient Satisfaction Questionnaire Scores | Acceptability will be assessed using a patient satisfaction questionnaire. The 5 Items on the patient satisfaction questionnaire are rated on a 4 likert scale with higher scores on the indicating better perceptions of treatment. Total satisfaction of treatment can be obtained by averaging scores across the 5 items. | Once at end of treatment (up to 9 weeks). |
| Feasibility of the intervention | Feasibility will be analyzed by examining adherence to the treatment protocol checklist. An average score of 80% treatment adherence for all participants will be used as a threshold to define the feasibility of this intervention. | 4 weeks of treatment following the 3-to 5-week baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Brief Experiential Avoidance Questionnaire | The brief experiential avoidance questionnaire (BEAQ) is a 15-item questionnaire that assesses avoidance of unwanted internal experiences, such as uncomfortable emotions, thoughts, memories, or sensations. The BEAQ has a range of 15-90, with high scores indicating more experiential avoidance. | Up to 15 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica Burris, Ph.D. | University of Kentucky | Study Director |
| Shannon Sauer-Zavala, Ph.D. | University of Kentucky | Study Director |
| Troy J.J. Hubert, M.S. | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40506 | United States |
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| Label | URL |
|---|---|
| A Github repository hosting data, analytic plan, and analytic R code. | View source |
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De-identified data for participants will be shared. This includes data used for primary analysis, a data dictionary defining all variables, a data analytic plan, and R code used for analysis. All IPD will be hosted on OSF and Github.
IPD and supporting information will be released before the completion of the first participant and stored after the completion of the study. Data analytic plan and analytic code will be stored on github indefinitely.
The full de-identified dataset will be released by PI to other researchers upon request. The small de-identified dataset of variables used for primary analysis, the data dictionary, data analytic plan, and the R analytic code will be stored on Github and OSF.
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| ID | Term |
|---|---|
| D003130 | Combat Disorders |
| D013313 | Stress Disorders, Post-Traumatic |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D007171 | Implosive Therapy |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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Acceptability and Feasibility using a Single Case Experimental Design
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| Changes in the posttraumatic cognitions inventory-9 (PTCI-9) | The PTCI-9 is a 9-item self-report that assesses posttraumatic cognitions following traumatic experiences. Items on the PTCI-9 are scored on a likert scale from 0 (Strongly Disagree) to 7 (Strongly Agree) and are averaged for a total score ranging from 0-7. Higher scores indicate higher levels of post-traumatic cognitions. | Up to 15 weeks. |
| Changes in the positive and negative valence affect schedule (PANAS) | The negative affect subscale of the PANAS will be anchored to participants' Criterion A (i.e., index) trauma and used to assess for negative affect related to participants' PTSD over the past week. The negative affect subscale is a 10-item self-report measure rated on a Likert scale from 1 (Very slightly or not at all) to 5 (Extremely), with summed scores ranging from 10 to 50. Higher scores indicate higher levels of negative emotions and affect. | Up to 15 weeks. |
| D003887 | Desensitization, Psychologic |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |